Device recall
Z-2655-2017: SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray…
FDA device recall · Class II · Shimadzu Medical Systems Usa Com
Key facts
| Recall number (Z-number) | Z-2655-2017 |
|---|---|
| Recall event | 77351 |
| Product | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals |
| Product code | KPR |
| Recalling firm | Shimadzu Medical Systems Usa Com |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 1, 2019 |
| 510(k) numbers | K152294 |
| FEI number | 1000125362 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database